Mouthpiece

ABSTRACT

A mouthpiece includes a first body configured to be secured over one or more teeth of a user. The first body comprises a frame for location about at least one of a molar or a premolar of user, as a first bite pad between upper teeth and lower teeth. The first bite pad is molded in the frame while in situ in the mouth of the user and the first bite pad is formed by a PVS material. The first bite pad is in contact with at least one of a molar or a premolar of user, and the first bite pad defines an exterior shape of at least a portion of the teeth of a user. There is a similar second body with a connector between the first body and the second body and together these form the appliance for the user.

RELATED APPLICATION

This application is a divisional of U.S. application Ser. No.13/541,209, filed Jul. 3, 2012, the contents of which are incorporatedby reference herein in its entirety.

FIELD OF DISCLOSURE

This disclosure relates to mouthpieces. In particular, the disclosureconcerns oral devices for spacing the occlusal surfaces of the teeth ofa user. This spacing, when in the correct position, can preventconcussions, enhance athletic ability, improve sleep, and reduceheadaches and temporomandibular disorders.

BACKGROUND

Different mouthpieces or mouthguards are known. They all have adisadvantage in relation to the form and complexity of forming good fitsfor each mouth, and in the nature of forming what should be regarded asthe best fit to improve the prevention of clenching of the mouth whenthis should be avoided, and minimize concussion during high impact.

There is a need for a mouthpiece and mouthguard, and a method of formingsuch a mouthpiece and mouthguard, which overcomes the disadvantages ofknown mouthpieces and mouthguards that is better than existingmouthguards and methods of making these mouthguards.

There is also a need to assist in attaining the MORA effect or anorthopedic location, a harmonious neuromuscular balance of the musclesof the jaw, teeth and jaw joint (tmj) that translates into increasedstrength, balance and flexibility for each user. Current devices do noteasily achieve this.

Many athletes strive to be the best they can be. They eat right, theywork out, and they take vitamin supplementation. However, if they arestructurally out of alignment, they will struggle harder and work harderto achieve optimum results. The average human head weighs ten pounds.This is the weight of an average bowling ball. This “bowling ball” sitsforward of our bodies and the muscles must maintain our heads over ourbodies. Releasing some of the load the body is using to hold one's headhelps to alleviate stress on the central nervous system (cns), whichtranslates into the burst of energy, better balance, and increasedflexibility that patients are experiencing. This theory has beensupported by many scientific journals specifically: Arent, Shawn,McKenna, Jennifer, and Golem, Devon (2010) Effects of a neuromusculardentistry-designed mouthguard on muscular endurance and anaerobic power:Comparative Exercise Physiology 7(2); 73-79; Cambridge University Press.The contents of this study are incorporated by reference herein.

SUMMARY OF THE DISCLOSURE

The disclosed mouthpiece is designed to help the individual achieve anoptimized physiological position.

An oral appliance for a user comprises the following components.

A first body is configured to be secured over one or more teeth of auser. The first body comprises a frame for location about at least oneof a molar a premolar of user, and a first bite pad between upper teethand lower teeth. In one form, the location of the frame lays over themolars and premolars of the lower and upper teeth and is hollow in thecenter. The first bite pad is molded in the frame while in situ in themouth of the user and the first bite pad is formed by a PVS material.The first bite pad is in contact with at least one of a molar a premolarof user, and the first bite pad defines an exterior shape of at least aportion of the teeth of a user.

A second body is configured to be secured over one or more teeth of auser. The second body comprises a frame for location about at least oneof a molar a premolar of user, a second bite pad between upper teeth andlower teeth. The second bite pad is molded in the frame while in situ inthe mouth of the user and the second bite pad is formed by a PVSmaterial. The second bite pad is in contact with at least one of a molara premolar of user. In one form, the location of the frame lays over themolars and premolars of the lower and upper teeth and is hollow in thecenter. In one form, the location of the frame lays over the molars andpremolars of the lower and upper teeth and is hollow in the center. Thesecond bite pad defines an exterior shape of at least a portion of theteeth of a user.

There is a connector between the first frame and the second framethereby connecting the first body and second body together and formingwith the first body and second body the appliance for the user.

A device, methods and kit in accordance with the present disclosure mayresolve many of the needs and shortcomings of known devices and methodand provide additional improvements and advantages.

The disclosed mouthguard prevents the completion of the clenchingmechanism, and is comfortable and unobtrusive and does not impedebreathing or speaking.

The custom manufacture of oral appliances based on the users' teeth isattained. The custom manufacture is not laborious and expensive, and issimple and the manufacture of the oral appliance in reduced the time andeffort and with great accuracy is possible. Adequate fit and comfort isthereby attained.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to further explain the characteristics of the disclosure, thefollowing embodiments of an improved oral appliance according to thedisclosure are given as an example only, without being limitative in anyway, with reference to the accompanying drawings, in which:

FIG. 1 illustrates a kit with two different PVS substances, forinstance, poly vinyl siloxane base and catalyst, the frame of the mouthguard, calipers for measuring teeth to see how much space is needed, andinstruction with a link to a video and a pair of gloves.

FIG. 2 is perspective view of separation of the first and second bodies,including the frame and connector.

FIG. 3 is perspective view of the connected first and second bodies,including the frame and connector.

FIG. 4 shows the 2 different epoxies poly vinyl siloxane base andcatalyst, separately in the gloved hand.

FIG. 5 shows the 2 different epoxies poly vinyl siloxane base andcatalyst between the gloved hand being mixed together and then rollingit out like a log.

FIG. 6 shows the 2 different epoxies poly vinyl siloxane base andcatalyst, like a log divided in half and put into the frame. It can alsobe stripped across the upper teeth for higher impact sports to helpprevent tooth evulsion or fracture.

FIG. 7 shows the frame in the mouth and the use of the saw tooth tool tobite down on for a given measurement. This measurement is calculated bythe patient. It is used for the patient to help find the optimumposition that will get the patient in the zone. This position ispre-calculated and is easy to read from a chart. The patient uses theplastic caliper to determine the width of their central incisor and thelength of their teeth together. The chart gives them their “goldenvertical”. The patient subtracts their vertical from the goldenvertical. The amount of mm is how much the open you want to keep thebite open while the silicone sets. That mm step guide is what thepatient uses to close into the proper golden vertical.

FIG. 8 shows this process of FIG. 7 in cross section and shows the jawalignment and tooth separation.

FIG. 9 shows the finished oral appliance product.

FIG. 10A shows a first alternative oral appliance product and theseparable frames used for making the oral appliance product.

FIG. 10B shows an opposite view of the first alternative oral applianceproduct and the separable frames used for making the oral applianceproduct, with the PVS formed portions of the appliance product in theframes.

FIG. 11A shows a second alternative oral appliance product with theseparable frames used for making the oral appliance product withextended frames.

FIG. 11B shows a view of the second alternative oral appliance productand the separable frames used for making the oral appliance product withcontracted frames.

FIGS. 12A and 12B are perspective views showing a multi positional formof the connector with the first and second bodies, and also showing theframe. The connector has a lock formation to permit the connector totake up different positions.

FIG. 13 is a perspective view showing an integrated single piece form ofdevice with the first and second bodies, and also showing the frame.

FIGS. 14A, 14B and 14C are perspective views showing an integratedsingle piece form of device with the first and second bodies, and alsoshowing the frame, in respectively each of three different sizes: small,medium and large and can be part of the kit.

FIG. 15A is a perspective view and FIG. 15B is a cross-sectional viewshowing an integrated single piece form of device with the first andsecond bodies which are integrated with and into the hollow frame.

The figures are illustrated for ease of explanation of the presentdisclosure only; the extensions of the Figures with respect to number,position, relationship and dimensions of the parts to form theembodiment are within the skill of the art after the followingdescription has been read and understood. The exact dimensions anddimensional proportions to conform to specific force, weight, strength,and similar requirements are within the skill of the art after thefollowing description has been read and understood. The terms such as“inferior,” “superior,” “anterior,” “posterior,” “proximal,” “distal,”“facial,” “buccal,” “labial,” “oral,” “lingual,” “palatal,” “distal,”“mesial,” and similar positional and/or relative terms are terms thatshould be understood with reference the structures shown in the drawingsand as they used by those skilled in the art.

DETAILED DESCRIPTION OF THE DISCLOSURE

An oral appliance for a user comprises the following components:

A first body is configured to be secured over one or more teeth of auser.

The first body 16 comprises a frame 38 for location about at least oneof a molar a premolar of user, a first bite pad 12 between upper teethand lower teeth.

The first bite pad 12 is molded in the frame while in situ in the mouthof the user and the first bite pad is formed by a PVS material.

The first bite pad 12 is in contact with at least one of a molar, or apremolar of user, and the first bite pad defines an exterior shape of atleast a portion of the teeth of a user.

A second body 18 is configured to be secured over one or more teeth of auser.

The second body comprises a frame 40 for location about at least one ofa molar, or a premolar of user, a second bite pad 14 between upper teethand lower teeth.

The second bite pad 14 is molded in the frame while in situ in the mouthof the user and the second bite pad is formed by a PVS material.

The second bite pad 14 is in contact with at least one of a molar, or apremolar of user, and the second bite pad defines an exterior shape ofat least a portion of the teeth of a user.

There is a connector 20 between the first frame 38 and the second frame40 thereby connecting the first body and second body together andforming with the first body and second body the appliance for the user.

Each body of the frame includes pair of side walls 37 and 39; and 41 and43. One wall is for location inside of a select number of teeth and asecond wall is for location outside the select number of teeth. The sidewalls are slightly bent so that they are concave to follow the contourof the teeth themselves. On the inside of the side walls there arelittle plastic bumps to facilitate PVS binding with and into the frame.

There is a first joinder component 11 for connecting the side walls a37and 39; and 41 and 43 and the connector 20. Also each body of the frameincludes a second joinder component 13 for connecting the side walls 37and 39; and 41 and 43 opposite to the first joinder component, andwherein each of the first and second joinders are preformedsubstantially flat elements for location between the teeth. The joinderssit behind the lower front teeth.

The first joinder component extends between the upper teeth and lowerteeth of a user.

The first and second bite pads are, respectively, for location between amolar or premolar. They are formed without a spacer between respectiveupper and lower molars of the upper teeth and lower teeth. In this sensethe frame is hollow.

The bite plates are formed with the PVS as discussed above.

The frame includes respective side walls which extend upwardly over partof the side of the upper molar or premolar, and respective side wallswhich extend downwardly over part of the side of the lower molar orpremolar. The side walls are slightly bent so that they are concave tofollow the contour of the teeth themselves. On the inside of the sidewalls there are little plastic bumps to facilitate PVS binding with andinto the frame.

The connector includes two components. One respective component isconnected to the first body, and the other respective component isconnected to the second body. Each component has a respective free end,and the free ends are releasably connectible together.

The connector also includes multiple sections. One section is connectedto the first body and being in a first plane. Another section isconnected to the second body and is located in the first plane. There isa third section between the first and second sections, and the thirdsection is located in a plane removed from the first plane of the firstand second sections.

The frame for each of the bite pads is formed such that it has twospaced straight lateral wall portions one for location in the interiorof the mouth and the other side for location outside the teeth. The twolateral portions can be sufficiently high to protrude beyond the bitepad which is formed. In other situations the height is shorter so thatthe material forming the pad extends over one or both the walls. Thefront and the rear of each frame include semicircular joinder portionsrespectively for joining the two walls together. The semicircularportions would extend over the teeth surface between the top and lowerteeth. In some cases there may be only a single joinder member at theforward portion.

A method of creating an oral insert uses the oral appliance. The insertis placed in the mouth of the user to fit with at least one of a molaror a premolar of user. A PVS formulation of a composition of multipleepoxies is placed in position between at least one of a molar or apremolar of user. The PVS is permitted to set and form the insert insitu.

The incisor edge of the upper front tooth and a lower front tooth of auser are aligned substantially edge to edge before having the PVS set.

The system of the disclosure enhances the MORA effect or theneuromuscular zone or the physiological correct position that enablespatients to get this burst of strength, better balance, and increasedflexibility. This is further described in Mouth Protectors: Give YourTeeth a Sporting Chance, American Dental Association, 1985. Stephen D.Smith, D.M.D., Muscular Strength Correlated to Jaw Posture and theTemporomandibular Joint, New York State Dental Journal, vol. 44, No. 7,August-September 1978. W. B. May, D.D.S., Reduction of Stress in theChewing Mechanism—Part III. These references are incorporated byreference herein. The disclosed mouthguard brings a patient relativelyaccurately into this zone. This zone varies on each individual and isspherical in shape like a football. The disclosed kit helps patientsachieve the results by finding the sweet spot in the jaw that takespressure off the central nervous system which results in relativelyincreased strength.

The use of the device helps each patient differently for differentconditions. If the patient bites very far forward (protrusive) it willhelp sleep by reducing the snore sound and allow patients to sleepbetter, and reduce sleep apnea.

When the guard is used in a position biting end to end or incisal edgeto incisal edge, the guard enhances the sports benefit and minimizestemporomandibular ailments such as headaches, neck pain, and ear and jawpain. The mouthguard can help re-capture the articulator disc in thecondylar jaw that may be out of alignment. Should a disc be off itstrack it can also be said to be without reduction or non-reduced.Closing the jaw in its natural arc of closure may prevent a disc frombecoming non reduced thus keeping it in correctly between the condyleand glenoid fossa.

A dentist using the kit and technique may use a “tens machine” to relaxthe muscles and allow the patient to close while tensing which will makethe disclosed device an orthotic or mouthpiece neuromuscular device. Adentist with a tens machine or a patient with an at-home tens machinecan use this prior to mixing the PVS to more fully relax the muscles ofthe jaw before closing into the unset PVS in the frame. The mandiblesits in a sling of muscles. This sling allows the jaw to rest in 6dimensions. After Tensing for 40 minutes or so, the muscles of the jawlose their habitual tension and rest at their natural resting length ora place of least electrical activity if measured with anelectromyography sensor. In this physiological resting position, thepatient gently closes into the wet PVS at the proper vertical dimensionand waits 60 seconds in that position until the PVS sets. This is a trueneuromuscular position that mimics a sophisticated orthotic produced bya professional dentist.

There are different manners to attain the physiologically correctposition of the mouth when the guard is formed in situ.

One method is for the user or patient to swallow while the PVS sets.This allows the jaw to go in all six dimensions: pitch yaw and roll a-p,lateral and up and down. This is a swallow bite that helps de programthe muscles in relaxing while the PVS sets. A preferred form of formingthe kit is to have the user swallow multiple times while the PVS issetting. This achieves a swallow bite and creates a relaxed state of thelower jaw, and promotes a physiologically correct positioning andforming of the guard for the user's mouth.

Another additive or alternative method uses a tool to for insertionbetween the incisor edges for facilitating alignment of the incisoredges. The tool includes a saw tooth end, and the end is for insertionbetween the top and bottom front incisors when forming the appliance.The saw tooth permits for establishing a different selected spacingbetween the top and bottom front incisors. The spacing is in accordancewith the selected saw tooth depth, and is in accordance with attaining adesired appliance. The edges are aligned thereby to attain a position ofthe golden vertical distance of the incisors.

The golden proportion is the mathematical definition of beauty and form.The proportion is 1 to 1.618. Being in this proportion typically is inalignment with proper function of the body.

The form of how it is calculated for teeth is set out as follows withreference to the following chart.

Golden Vertical

Ideal W:H ratio is 75-80%

H:W ratio is 1.29%

Measure width of centrals

Multiply this by 1.298

Width×1.298 mm=Length

Length×Golden Proportion (1.618)=Golden Vertical

Width of Maxillary Central×1.29=(length)×1.618=Golden Vertical.

The following chart is of use in determining the physiologically correctpositions.

Centrals Ideal Length Golden Vertical   7 mm   9 mm 14.5 mm   7.5 mm9.75 mm 15.75 mm     8 mm 10.5 mm 17 mm 8.5 mm   11 mm 17.75 mm     9 mm11.5 mm 18.5 mm   9.5 mm 12.25 mm  20 mm  10 mm   13 mm 21 mm 10.5 mm 13.5 mm 22 mm

Patients can find their own golden vertical and subtract that from theiractual vertical. This measurement is how far open is their mouth at thetime the silicon will set in the mouth when the patient closes end toend. The plastic caliper on one end and the stepped mm guide on theother assist in the user attaining the physiologically correct position.The chart provides a more exact mathematical measurement. The chart canbe used with just the width of central—then golden vertical.

The golden vertical calculations used with the system of the disclosureis simpler by eliminating the middle column of the above chart. Justwidth of central and then golden vertical can be used by using thenumber of golden vertical and the patient's own vertical.

Vertical is calculated when patients teeth are together. In such aposition the top of front tooth is aligned to bottom of bottom tooth.The golden vertical is subtracted from the user's own vertical to getthe amount the bite needs to open. If the number is a negative number,meaning that the patient's actual vertical is greater than the goldenvertical, and the patient should close incisal edge to incisal edge.

With these mathematical calculations, the tool and the mm stick of thetool are used to bite on during the setting of the PVS.

This is described in further detail.

Finding this physiological correct position utilizing the disclosedguard is described.

Utilizing the golden proportion concept that there is a mathematicaldefinition for form and function. A proportion that our bodies like tobe in which is 1 to 1.618. Utilizing this proportion can help patientsfind their optimum bite positions. See http://www.goldenmeangauge.co.uk.

The ideal perfect human bite is in golden proportion as the front teethare in proportion to the lower teeth when the teeth are closed. Thismeasurement is found by measuring the width of a front upper centralincisor. From that measurement, there is a mathematical determination tolocate the perfect length of the bite (vertical dimension) when theteeth are closed. Most patients are over-closed. They have worn theirteeth down over the years. By subtracting their own vertical dimensionsof their bites from the golden proportion vertical dimension allows thepatient to know how many mm thick their mouth appliance should be.

The disclosed bite stick tool allows the patient to stop their teethfrom coming too close together and allowing them to stop in theiroptimum golden vertical dimension. Once in this position, the patientshould swallow as the PVS sets. This allows the jaw to roll in all sixof its dimensions at rest.

Examples of Use

A first example is of a person who has worn his teeth halfway down overthe years. The user measures the width of his upper front centralincisor and finds out that it is 7 mm across. Looking at the disclosedeasy to read chart, the user notices that the golden vertical for acentral that is 7 mm across is 14.5 mm. The user then measures thevertical distance of his own bite using our plastic boley gauge which isonly 12 mm. The user then subtracts the 14.5 mm from the 12 mm of hisbite to get 2.5 mm. The 2.5 mm is the distance he wants to stop his biteshort when he places the PVS into the hollow holes of our guard insteadof closing his bite all the way down to incisal edge to incisal edge.

In a second example the patient should close on their natural arc ofclosure and stop 1 mm or so before their incisal edges of their teethcome together. Once there, have the patient relax and swallow as the PVSsets.

A kit 30 for forming the oral appliance 10 is also provided. The kit 30comprises a package 32 wherein there are two different PVS formulations34 and 36. The PVS formulations are of a nature that their interactionwith each other promotes setting of the combination PVS formulations asa PVS final set material.

The kit 30 also includes is a first body 16 or member comprising part ofa first frame 38 for location about at least one of a molar a premolarof user to form a first bite pad between upper teeth and lower teeth.The first bite pad is formed by molding it in the first frame 38 whilein situ in the mouth of the user and the first bite pad being formed bythe PVS material.

The kit 30 also includes a second body 18 or member comprising partcomprising a second frame 40 for location about at least one of a molara premolar of user to form a second bite pad between upper teeth andlower teeth. The second bite pad is molded in the second frame 40 whilein situ in the mouth of the user, and the second bite pad being formedby the PVS material.

The kit 30 also includes a connector 20 between the first frame 38 andthe second frame 40. This connects the first body 16 and second body 18together and forming the appliance 10 for the user. The connector canhave locks to enable locking in three or more different positions orwidths for wider or narrower mandibular arches. This makes the frame aone size fits all universal frame. The locks in the connector can beformed by protruding teeth on one connector components which fit intomating slots or holes in the mating part of the other connector.

The kit 30 includes a tool 42 for insertion between the upper incisoredges 44 and lower incisor edges 46, and is for facilitating alignmentof the incisor edges 44 and 46. The tool 42 includes a saw tooth end 48,the end being for insertion between the top and bottom front incisoredges 44 and 46 when forming the appliance 10. The saw tooth end 48permits for establishing a different selected spacing between the topand bottom front incisors edges 44 and 46. The spacing is in accordancewith the selected saw tooth depth, and in accordance with attaining adesired appliance 10.

The kit 30 has the two different PVS substances 34 and 36, the frameportions 38 and 40 of the mouth guard, the caliper end 50 of the tool 42for measuring teeth to determine how much space is needed. There is aninstruction sheet 52 with a link to a video and several pair of gloves54. The saw tooth end 48 for inserting between teeth when making themolds of the appliance 10.

After taking some measurement with the calipers 50, the saw tooth end 48is inserted between the front incisors edges 44 and 46 to obtain the“golden vertical” distance. This distance and the saw tooth end 48 ofthe caliper tool 42 are correlated to the 1 mm, 2 mmm etc. steps on theend 48 of the caliper tool 42.

The first body 16 is configured to be secured over one or more teeth ofa user, and the first body 16 comprises a composite structure. Thecomposite structure comprises at least a first bite pad 56, and thefirst bite pad 56 is in a position to contact at least one of a molar apremolar of user. The inner surface 58 of the bite pad has a shape of atleast a portion of the teeth of a user.

The second body 18 is configured to be secured over one or more teeth ofa user. The second body 18 comprises a composite structure, and at leasta second bite pad 60. The composite structure at the second bite pad 60is in a position to contact at least one of a molar a premolar of user.The inner surface 62 of the bite pad 60 has a shape of at least aportion of the teeth of a user.

The connector 20 defines a first mounting portion 64 and a secondmounting portion 66. The first mounting portion 64 is secured to thefirst body 16 and the second mounting portion 66 secured to the secondbody 18.

The connector 20 extends from a buccal edge of the first body 16 and hasa first mesial bend. The connector 20 extends from a buccal edge of thefirst body 16 and has a second mesial bend. An arch 68 of the connector20 extends between the first mesial bend and the second mesial bend withthe first mesial bend and the second mesial bend. The arch 68 of theconnector 20 can be location adjacent to one of incisors of the user andthe gum line adjacent to the incisors of the user. The connector lies onthe lingual of the lower central incisors. When the frame lies passivein the mouth it preferably is not outwardly visible since the connectoris behind the front lower teeth.

The process of creating the molded parts of the bite pads 56 and 60 isaffected once the measurements are taken and how much space and the sizehave been determined. There can be two different epoxies 34 and 36.These are mixed together, for instance, between the hands 70 and rolledout like a log 72. The log 72 is then divided in half 74 and 76 and putin the respective frames or trays 38 and 40. The frames or trays 38 and40 as connected by the connector 20 are placed is in the mouth. Then thesaw tooth 48 is used to bite down on for a given measurement as had beenobtained by the caliper 50.

FIG. 8 shows this process in cross section and helps show the jawalignment and tooth separation. FIG. 9 show a finished oral applianceproduct 10 in a front top perspective view as an exemplary embodiment ofan oral appliance 10 to be positioned on the upper teeth a user inaccordance with aspects of the present disclosure.

Various embodiments of oral appliances 10 are illustrated throughout thefigures for exemplary purposes. The illustrated oral appliance 10includes the frame 38 with at least a first bite pad 12 and a secondbite pad 14 interconnected by a connector 20. The first bite pad 12 maybe defined by, secured to, or integral within a first body 16.Similarly, the second bite pad 14 may be defined by, secured to, orintegral with a second body 18. The first body 16 and the second body 18may be configured to secure and/or position the first bite pad 12 andthe second bite pad 14 at the desired position relative to the occlusalsurface of the teeth.

The bite pads 12 and 14 do not include a spacer in one form of thedisclosure. In some other forms of the disclosure there could a spacerelement in each of the first and second bodies, the spacer elementsextending in part or in whole in the space between the occlusal surfacesof the top and bottom teeth.

The bite pads 12, 14 may be configured to space the occlusal surface ofone or more premolars and molars when the teeth of a user are clenchedand may be generally configured to reduce or alleviate pressure at thetemporomandibular joint when the user's teeth are clenched. The bitepads 12, 14 may also or alternatively be generally configured to protectthe teeth and/or temporomandibular joint of a user when the user issubject to a blow to the jaw, head or otherwise receives an impactingforce that may travel to or through the jaw. This minimizes the degreeof concussion suffered by the user.

The oral appliance 10 may be configured to be received over at leastsome of the upper teeth or lower teeth of a user. The first body 16 andthe second body 18 are interconnected by connector 20 configured to bepositioned against the lingual or palatal surface of the gums. The firstbite pad 12 and the second bite pad 14 are generally configured to bepositioned over at least one of the lower molars on each side of auser's jaw when worn by a user. When the upper teeth and the lower teethof a user are juxtaposed, the first bite pad 12 and the second bite pad14 may be positioned between at least some of the upper molars and/orpremolars and some of the lower molars and/or premolars. In certainembodiments, the first bite pad 12 and the second bite pad 14 may coverat least a portion of the second premolar and at least a portion of thefirst molar on each side of the jaw of a user.

The connector 20 secures the first bite pad 12 to the second bite pad14. The connector 20 may secure the first bite pad 12 to the second bitepad 14 by being secured to the first body 16 and the second body 18 towhich the first bite pad 12 and the second bite pad 14 are respectivelysecured or otherwise integrated. The connector 20 is typicallyconfigured to extend as an arch around the lingual or palatal side ofthe front teeth of a user. In certain embodiments,

The connector 20 may extend along or just below the gum line on an oralappliance 10 configured for the lower teeth or along or just above on anoral appliance 10 configured for the upper teeth. This positioning ofthe connector can reduce the perceived obtrusiveness of the bar withinthe mouth and can also reduce the impact on a user's speech. By placingthe connector on the lingual of the lower front teeth, this allows thelower jaw to be non-obtrusive with the upper teeth. The lower jaw hasthe freedom to go into a protrusive position if need be and theconnector is not seen by the patient.

The frame and/or connector may be made from various metals, metalalloys, various polymers, various laminates, various natural materialsor other synthetic materials as known to those skilled in the art.

The components are configured to conform to reduce the obtrusiveness ofthe oral appliance 10 in the mouth of the user. The portion may includeflattened regions to conform to the gums and teeth of a user. Theportions may include a textured or otherwise treated surface to assistin the bonding between the material or materials that form the bodies16, 18 and the connector 20.

The first body 16 and the second body 18 may be composed of one or morelayers of materials. One example of this material which can be singlematerial or composition of different components of material is anExaflex (trademark) putty which is a vinyl polysiloxane impressionmaterial. It is a type O Putty made and/or distributed by GC AmericaInc., Alsip, Ill. 60803. There can be a base material and a catalystmaterial.

These materials can include ethyl-vinyl acetate (EVA); thermoplasticpolyolefin, various ethylene-based elastomers; various hydrocarbonresins (which are may be combined with EVA, thermoplastic polyolefin, orvarious ethylene-based elastomers), polycaprolactone (which may becombined with EVA), low-density polyethylene, high densitypoly-ethylene, polycarbonate and/or various polymers, laminates andother materials that will be known by those skilled in the art. Thecomposite material may be a pre-laminated sheet including a layer ofpolycarbonate bound to a layer of polyester urethane which is availableunder the trade name Durasoft® from the Scheu Dental Co. located inIserlohn, Germany. Typically, these materials are selected with adurometer (hardness) of between 70 A to 96 A or between 55D and 90D.

At least a portion of the inferior surface of the first body 16 and thesecond body 18 may conform to the shape of the teeth of the user. Thiscan enhance the fit, comfort and retention of the oral appliance 10 inthe mouth of a user. At least a portion of a superior surface of thefirst body 16 and the second body 18 may also be shaped to correspond tothe shape of the teeth of a user. In certain aspects, this shape mayenhance the comfort and aesthetics of the oral appliance 10.

The first body 16 and the second body 18 each form a mesial body edge.The mesial body edge is typically configured to be positioned at ordistal to the canines when the oral appliance is positioned in the mouthof a user. This can reduce the comfort of the device by eliminatingcoverage of the lingual side of the incisors that can cause irritationto the tongue of users.

The first body 16 and the second body 18 also each form a distal bodyedge. The distal body edge is typically configured to be positioned ator mesial to the second molar or, when present, the third molar when theoral appliance is positioned in the mouth of a user.

At least a portion of the first body 16 and the second body 18 maydefine the first bite pad 12 and the second bite pad 14. The bite pads12, 14 of oral appliance 10 may be configured to at least reducepressure in the temporomandibular joint as the lower mandible isclenched. In certain aspects, the oral appliance 10 may tend to directthe mandibular condyle downward from the articular fossa in response anattempt by a user to clench their teeth. In other aspects, the oralappliance 10 may tend to direct the mandibular condyle downward andforward from the articular fossa in response an attempt by a user toclench their teeth.

The bite pads 12, 14 are generally configured to define an externalocclusal surface to contact at least a portion of the occlusal surfaceof the opposing teeth and a channel occlusal surface to contact theocclusal surfaces of the teeth relative to which the oral appliance 10is secured. At least a portion of the channel occlusal surface iscoextensive with the channel occlusal surface and may include thecharacteristics and features of the occlusal surface. The bite pads 12,14 are generally configured to be positioned adjacent the occlusalsurfaces of at least one of the canines, the premolars and the molarswith at least one bite pad 12, 14 on each side of a user's mouth.Typically, the bite pads 12, 14 are positioned over the occlusalsurfaces of at least one the premolars and at least one of the molars.In other aspects, the bite pads 12, 14 may be solely positioned over theocclusal surfaces of one or more molars.

The mesial body edge of the first body 16 is positioned at mesial of thefirst premolar and the distal body edge of the first body 16 ispositioned at distal of the second molar to position the first body 16between at least the first premolar and second molar for exemplarypurposes. Similarly, the mesial body edge of the second body 18 ispositioned at mesial of the first premolar and the distal body edge ofthe second body 18 is positioned at distal of the second molar toposition the second body 18 between at least the first premolar andsecond molar for exemplary purposes.

The connector 20 extends around the front of the mouth along the lingualsurface of the gums just under the gum line. The connector 20 extendsaway from lingual body edges of the first body 16 and the second body 18toward or through a transverse plane defined at one or more points alongthe lingual body edges. The connector 20 further includes a mesial bendto position an arch of the connector 20 at or below the gum line of auser. The arch may be positioned substantially coplanar in a transverseplane defined at one or more points along the lingual body edge of thefirst body 16 and the second body 18.

The arch may be positioned below a transverse plane defined at one ormore points along the lingual body edge of the first body 16 and thesecond body 18. In embodiments configured for use on the upper teeth,the arch may be positioned above a transverse plane definedsubstantially at the lingual body edge of the first body 16 and thesecond body 18.

The disclosed system is an innovative universal fitting frame. The factthat it is hollow over the molar and premolars allows for variedthinness or thickness for our mouth piece. It allows for patients whohave uneven thickness from the right side to the left side or from theanterior portion to the posterior portion. It accommodates anyinadequacies in the bite and evens them out.

The self-setting PVS allows the user to mix the base and catalyst whichhelps customize the amount of material that is needed on each side ofthe frame.

This allows the lower jaw to move into its natural resting positionwithout being restricted by the maxilla (upper jaw) for patients whohave deep over-bites. The system allows the jaw to move forward into itsnatural most comfortable position. It frees the mandible.

It is intended to cover various modifications and similar arrangementsincluded within the spirit and scope of the claims, the scope of whichshould be accorded the broadest interpretation so as to encompass allsuch modifications and similar structures. For instance, the distances,spaces, sizes and measurements can vary relative to each other.

The present disclosures provide oral appliances and methods for theirmanufacture. The figures generally illustrate embodiments of oralappliances and methods for their manufacture in accordance with thepresent disclosures.

In some other exemplary embodiments of the appliance there are thedifferent features of the bite pads, frames, and connector.

As shown in FIGS. 10A and 10B there is a first alternative oralappliance product and the separable frames used for making the oralappliance product. The PVS formed portions of the appliance product areshown in the frames and the PVS also extends in a channel 78 in part ofthe connector 20. As such the PVS forms a strip 80 between the bite pads56 and 60.

Both the top of the bite pads 56 and 60 form indentation surfaces 58 and62 respectively for the teeth. The under surfaces of the bite pads 56and 60 form indentation surfaces 82 and 84 respectively for the pads 56and 60.

FIGS. 11A and 11B show a second alternative oral appliance product withthe separable frames used for making the oral appliance product. In thisembodiment the frames 38 and 40 each have two parts forming adjustableside walls 86 and 88 for the frame 38 and side walls 90 and 92 for theframe 40. In this manner the first and second bodies 16 and 18respectively can be adjusted in size accord to teeth placement of auser. Adjustment can be effected by slots 94 which engage pins extendingfrom the mating parts of the two part frames 38 and 40.

In FIGS. 12A and 12B illustrate a connector 114 which can be located inthree different positions with spaced teeth 116 in a first part of theconnector which can lock in desired positions with mating teeth 118 in athe second part of the connector. The side walls 104, 106 108 and 110are curved to match the shape of the jaw. There are also spacedprojections 112 on the inside faces of the side walls about which thePVS can set. The projections add to the security of the connection andPVS with the sidewalls.

In FIG. 13 there is shown an integrated single piece oral appliancewhere the connector is a single piece. There are also sensors 126 and128 on the side walls which can monitor different physiologicalconditions in the mouth and or about the teeth. Such conditions can betemperature and different chemical concentrations, force and these canbe transmitted by the sensor to a receiver for analysis.

As shown in FIGS. 14A, 14B and 14C there can be a kit formed oralappliances respectively each of three different sizes: small, medium andlarge. This kit can contain one or more integrated devices of one/ormore different sizes and/or include devices of variable widths.

As shown in FIG. 15A and FIG. 15B there is an integrated single pieceform of device with the first and second bodies which are integratedwith and into the hollow frame which extends from the molars on one sideof the jaw to the molars on the other side of the jaw. The two framesare connected by a cross member 130. The walls of the frame are shownrelatively more curved to conform to the curved shape of the teeth. Insome cases the hollow frame can be formed by two or more components.

In different forms the frame is part of the final oral appliance product10. In other forms the frame is removed and bite pads and a connecter asshown in FIG. 10A is the oral appliance product 10. The connector 20 canbe of a nature that it is an integral single format structure.Alternatively, there can be the two components which are releasablejoined through the integrating pair of spaced partly flexible pins 96 inthe receiving slot 98.

The particular exemplary embodiments of the oral appliances illustratedin the figures have been chosen for ease of explanation andunderstanding of the various aspects of the present disclosures. Theseillustrated embodiments are not meant to limit the scope of coverage butinstead to assist in understanding the context of the language used inthis specification and the appended claims. Accordingly, variations oforal appliances including claimed aspects of the disclosures differentfrom the illustrated embodiments may be encompassed by the appendedclaims.

1-21. (canceled) 22: An oral appliance for a user comprising: a firstbody configured to be secured over one or more teeth of a user, thefirst body comprising a first frame for location about at least one of amolar a premolar of user, a first bite pad between upper teeth and lowerteeth, the first bite pad being adapted to be molded in the frame whilein situ in the mouth of the user and the first bite pad being adapted tobe formed and adapted to be set in situ by a PVS material, the firstbite pad being in contact with at least one of a molar a premolar ofuser, and the first bite pad defining an exterior shape of at least aportion of the upper teeth and the lower teeth of a user; a second bodyconfigured to be secured over one or more teeth of a user, the secondbody comprising a second frame for location about at least one of amolar or a premolar of user, a second bite pad between upper teeth andlower teeth, the second bite pad being adapted to be molded in the framewhile in situ in the mouth of the user and the first bite pad beingadapted to be formed and adapted to be set in situ by a PVS material,the second bite pad being in contact with at least one of a molar or apremolar of user, and the second bite pad defining an exterior shape ofat least a portion of the upper teeth and the lower teeth of a user; therespective first frame and the second frame, prior to having therespective bite pads in place being hollow without an intervening spacerbetween a top and a bottom of each of the respective frames; and aconnector between the first frame and the second frame therebyconnecting the first body and second body together and forming with thefirst body and second body, the appliance for the user, and theconnector being adapted for location solely within the mouth, andfurther being adapted to be located on the inside of the lower teeth.23: A method of creating an oral insert using the oral appliance ofclaim 22 wherein the insert is placed in the mouth of the user to fitwith at least one of a molar or a premolar of user, and PVS is placed inposition between the at least one of a molar or a premolar of user, andthe PVS is permitted to set and form the insert in situ. 24: The methodof claim 23 wherein the incisor edge of the upper front tooth and alower front tooth of a user are aligned substantially edge to edgebefore having the PVS set. 25: The method of claim 24 including using atool to for insertion between the incisor edges, for facilitatingalignment of the incisor edges. 26: The method of claim 25 wherein thetool includes a saw tooth end, the end being for insertion between thetop and bottom front incisors when forming the appliance, and whereinthe saw tooth permits for establishing a different selected spacingbetween the top and bottom front incisors, the spacing being inaccordance with the selected saw tooth depth, and in accordance withattaining a desired appliance. 27: The method of claim 24 wherein theedges are aligned thereby to attain a position of the golden verticaldistance of the incisors. 28: A method of claim 27 wherein the user islocates the mouth in the swallow bite position while the PVS ispermitted to set and form the insert in situ. 29: A method of permittinga user to enhance a MORA effect or the neuromuscular zone or thephysiological correct position by creating an oral insert using the oralappliance of claim
 22. 30: A method of permitting a user to attain aposition to reduce sleep apnea by use of the oral appliance of claim 22wherein the insert is placed in the mouth of the user to fit with atleast one of a molar or a premolar of user, and PVS is placed inposition between the at least one of a molar or a premolar of user, andthe PVS is permitted to set and form the insert in situ, while thepatient bites protrusively. 31: A method of permitting a user to attaina position to re-capture the articulator disc in the condylar jaw by useof the oral appliance of claim 22 wherein the insert is placed in themouth of the user to fit with at least one of a molar or a premolar ofuser, and PVS is placed in position between the at least one of a molaror a premolar of user, and the PVS is permitted to set and form theinsert in situ, while the patient bites end to end or incisal edge toincisal edge, such that the guard so formed enhances is adapted toreduce temporomandibular ailments, selectively at least one of aheadache, neck pain, ear and jaw pain. 32: A kit for forming the oralappliance of claim 22 comprising package of two different PVSformulations, the PVS formulations being of a nature that theirinteraction with each other promotes setting of the combination PVS as aPVS material, a first body comprising a frame for location about atleast one of a molar a premolar of user to form a first bite pad betweenupper teeth and lower teeth, the first bite pad being for molding in theframe while in situ in the mouth of the user and the first bite padbeing formed by the PVS material; a second body comprising a frame forlocation about at least one of a molar a premolar of user to form asecond bite pad between upper teeth and lower teeth, the second bite padbeing for molding in the frame while in situ in the mouth of the userand the second bite pad being formed by the PVS material; and aconnector between the first frame and the second frame therebyconnecting the first body and second body together and forming theappliance for the user. 33: The kit of claim 32 including a tool forinsertion between the incisor edges, for facilitating alignment of theincisor edges. 34: The kit of claim 33 wherein the tool includes a sawtooth end, the end being for insertion between the top and bottom frontincisors when forming the appliance, and wherein the saw tooth permitsfor establishing a different selected spacing between the top and bottomfront incisors, the spacing being in accordance with the selected sawtooth depth, and in accordance with attaining a desired appliance. 35:An oral appliance for a user comprising: a first body configured to besecured over one or more teeth of a user, the first body comprising afirst frame for location about at least one of a molar a premolar ofuser, a first bite pad between upper teeth and lower teeth, the firstbite pad being adapted to be molded in the frame while in situ in themouth of the user and the first bite pad being adapted to be formed andadapted to be set in situ by a PVS material, the first bite pad being incontact with at least one of a molar a premolar of user, and the firstbite pad defining an exterior shape of at least a portion of the upperteeth and the lower teeth of a user; a second body configured to besecured over one or more teeth of a user, the second body comprising asecond frame for location about at least one of a molar or a premolar ofuser, a second bite pad between upper teeth and lower teeth, the secondbite pad being adapted to be molded in the frame while in situ in themouth of the user and the first bite pad being adapted to be formed andadapted to be set in situ by a PVS material, the second bite pad beingin contact with at least one of a molar or a premolar of user, and thesecond bite pad defining an exterior shape of at least a portion of theupper teeth and the lower teeth of a user; the respective first frameand the second frame, prior to having the respective bite pads in placebeing hollow without an intervening spacer between a top and a bottom ofeach of the respective frames; a connector between the first frame andthe second frame thereby connecting the first body and second bodytogether and forming with the first body and second body, the appliancefor the user, and the connector being adapted for location solely withinthe mouth, and further being adapted to be located on the inside of thelower teeth; and the first body, the second body and the connector beinga continuous body encompassing the teeth in an arch between the molarand premolars on one side of the mouth and the molar and premolars onthe other side of the mouth. 36: A method of creating an oral insertusing the oral appliance of claim 35 wherein the insert is placed in themouth of the user to fit with at least one of a molar or a premolar ofuser, and PVS is placed in position between the at least one of a molaror a premolar of user, and the PVS is permitted to set and form theinsert in situ. 37: The method of claim 36 wherein the incisor edge ofthe upper front tooth and a lower front tooth of a user are alignedsubstantially edge to edge before having the PVS set. 38: The method ofclaim 37 including using a tool to for insertion between the incisoredges, for facilitating alignment of the incisor edges. 39: The methodof claim 38 wherein the tool includes a saw tooth end, the end being forinsertion between the top and bottom front incisors when forming theappliance, and wherein the saw tooth permits for establishing adifferent selected spacing between the top and bottom front incisors,the spacing being in accordance with the selected saw tooth depth, andin accordance with attaining a desired appliance. 40: The method ofclaim 37 wherein the edges are aligned thereby to attain a position ofthe golden vertical distance of the incisors. 41: A method of claim 37wherein the user is locates the mouth in the swallow bite position whilethe PVS is permitted to set and form the insert in situ. 42: A method ofpermitting a user to enhance a MORA effect or the neuromuscular zone orthe physiological correct position by creating an oral insert using theoral appliance of claim 35.